The DOI matches its Crossref record; 58 of the 61 references it cites were found in a registry or an index; none of the 18 sources its claims cite is checked for support yet.
A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss: AREDS Report No. 8
Open accessAbstract
BACKGROUND: Observational and experimental data suggest that antioxidant and/or zinc supplements may delay progression of age-related macular degeneration (AMD) and vision loss. OBJECTIVE: To evaluate the effect of high-dose vitamins C and E, beta carotene, and zinc supplements on AMD progression and visual acuity. DESIGN: The Age-Related Eye Disease Study, an 11-center double-masked clinical trial, enrolled participants in an AMD trial if they had extensive small drusen, intermediate drusen, large drusen, noncentral geographic atrophy, or pigment abnormalities in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye. At least 1 eye had best-corrected visual acuity of 20/32 or better. Participants were randomly assigned to receive daily oral tablets containing: (1) antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg); (2) zinc, 80 mg, as zinc oxide and copper, 2 mg, as cupric oxide; (3) antioxidants plus zinc; or (4) placebo. MAIN OUTCOME MEASURES: (1) Photographic assessment of progression to or treatment for advanced AMD and (2) at least moderate visual acuity loss from baseline (> or =15 letters). Primary analyses used repeated-measures logistic regression with a significance level of.01, unadjusted for covariates. Serum level measurements, medical histories, and mortality rates were used for safety monitoring. RESULTS: Average follow-up of the 3640 enrolled study participants, aged 55-80 years, was 6.3 years, with 2.4% lost to follow-up. Comparison with placebo demonstrated a statistically significant odds reduction for the development of advanced AMD with antioxidants plus zinc (odds ratio [OR], 0.72; 99% confidence interval [CI], 0.52-0.98). The ORs for zinc alone and antioxidants alone are 0.75 (99% CI, 0.55-1.03) and 0.80 (99% CI, 0.59-1.09), respectively. Participants with extensive small drusen, nonextensive intermediate size drusen, or pigment abnormalities had only a 1.3% 5-year probability of progression to advanced AMD. Odds reduction estimates increased when these 1063 participants were excluded (antioxidants plus zinc: OR, 0.66; 99% CI, 0.47-0.91; zinc: OR, 0.71; 99% CI, 0.52-0.99; antioxidants: OR, 0.76; 99% CI, 0.55-1.05). Both zinc and antioxidants plus zinc significantly reduced the odds of developing advanced AMD in this higher-risk group. The only statistically significant reduction in rates of at least moderate visual acuity loss occurred in persons assigned to receive antioxidants plus zinc (OR, 0.73; 99% CI, 0.54-0.99). No statistically significant serious adverse effect was associated with any of the formulations. CONCLUSIONS: Persons older than 55 years should have dilated eye examinations to determine their risk of developing advanced AMD. Those with extensive intermediate size drusen, at least 1 large druse, noncentral geographic atrophy in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye, and without contraindications such as smoking, should consider taking a supplement of antioxidants plus zinc such as that used in this study.
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92 Own result · 36 Own method · 13 Own interpretation · 9 No basis given · 4 Sources not found · 4 No full text of the sources · 4 Not checked yet
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Odds reduction estimates increased when these 1063 participants were excluded (antioxidants plus zinc: OR, 0.66; 99% CI, 0.47-0.91;zinc: OR, 0.71; 99% CI, 0.52-0.99;antioxidants: OR, 0.76; 99% CI, 0.55-1.05).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plaindirectn = 1,063- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The only statistically significant reduction in rates of at least moderate visual acuity loss occurred in persons assigned to receive antioxidants plus zinc (OR, 0.73; 99% CI, 0.54-0.99).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The 5-year estimated probability of progression to advanced AMD in either eye in participants with extensive intermediate drusen, large drusen, or noncentral GA (Category 3) was 18%.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > By AMD Category
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Odds reduction estimates increased when these 1063 participants were excluded (antioxidants plus zinc: OR, 0.66; 99% CI, 0.47-0.91;zinc: OR, 0.71; 99% CI, 0.52-0.99;antioxidants: OR, 0.76; 99% CI, 0.55-1.05).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plaindirectn = 1,063- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“No statistically significant serious adverse effect was associated with any of the formulations.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Only 15 participants in Category 2 (3 in the placebo arm) developed an AMD event by 5 years of follow-up.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STATISTICAL ANALYSES
plainn = 15- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The ORs for zinc alone and antioxidants alone are 0.75 (99% CI, 0.55-1.03)and 0.80 (99% CI, 0.59-1.09),respectively.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Comparison with placebo demonstrated a statistically significant odds reduction for the development of advanced AMD with antioxidants plus zinc (odds ratio [OR], 0.72; 99% confidence interval [CI], 0.52-0.98).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants with extensive small drusen, nonextensive intermediate size drusen, or pigment abnormalities had only a 1.3% 5-year probability of progression to advanced AMD.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plainn = 1,063- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“We found that in approximately 8% of the identified cases of advanced AMD, based on central grading of color stereo photographs, the AMD lesions were not seen on subsequent yearly photographs.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STATISTICAL ANALYSES
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- It may state two separate claims as one. 38
- Probably not a substantial claim. 22
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Both zinc and antioxidants plus zinc significantly reduced the odds of developing advanced AMD in this higher-risk group.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plaindirectn = 1,063- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Among participants in Categories 3 and 4, an analysis of each treatment compared with placebo for the 257 participants who developed central GA in an eye prior to any documentation of neovascular disease in that eye resulted in OR estimates of 0.80 (99% CI, 0.48-1.32)for antioxidants; 0.76 (99% CI, 0.46-1.27)for zinc; and 0.75 (99% CI, 0.45-1.24)for antioxidants plus zinc.None of the ORs were stat”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Development of Neovascular AMD.
plainn = 257- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Serum levels of lutein and zeaxanthin decreased during the 5-year period, with median percent decreases in year 1 and year 5 of 2% and 13%, respectively, in the placebo arm, and from 7% to 33% in the other treatment arms; however, changes in the treatment arms were not significantly different from the placebo arm (PϾ.07).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Changes in Other Serum Levels
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants in the antioxidant arms were hospitalized less frequently for mild/moderate symptoms, eg, chest pain or discomfort, vasovagal episode, fever (7.4% vs 10.1%; P=.005), and more frequently for infections (1.6% vs 0.8%; P=.04).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Hospitalizations
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants in the zinc arms showed an excess of self-reported anemia (13.2% vs 10.2%; P=.004) but serum hematocrit levels showed no difference.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Potential Adverse Effects
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Median percent change in serum level of copper from baseline ranges from a 3% decrease to a 2% increase among all participants regardless of study medication assignment, indicating no differential effect of zinc oxide with added cupric oxide on copper levels.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Changes in Serum Levels of Antioxidants and Zinc
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“For Category 4 placebo participants the 5-year probability estimate was 28% and 17% for antioxidants plus zinc (antioxidants plus zinc: OR, 0.53; 99% CI, 0.30-0.94)(data not shown).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Marked Visual Acuity Loss.
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The estimated 5-year probability of this severe vision event from repeated-measures analysis was 17% for participants assigned to placebo compared with 14% for those assigned to antioxidants (OR, 0.80; 99% CI, 0.55-1.16),13% to zinc (OR, 0.75; 99% CI, 0.52-1.08),and 12% to antioxidants plus zinc (OR, 0.68; 99% CI, 0.46-1.01).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Marked Visual Acuity Loss.
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Circulatory adverse experiences were less frequent in the antioxidant arms than the nonantioxidant arms (0.3% vs 0.8%; P = .04)and more frequently reported in the zinc arms than the nonzinc arms (0.9% vs 0.3%; P=.01).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Adverse Experiences
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There is no evidence of treatment benefit in delaying the progression of AMD in participants who began the study in Category 2; all OR estimates cluster around 1.00 (data not shown).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Progression of AMD in Category 2 Participants
plainn = 28- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Benefit was statistically significant for the zinc vs no zinc main effect (OR, 0.76; 99% CI, 0.58-0.98),was suggestive for the zinc-alone arm (OR, 0.73; 99% CI, 0.51-1.04),and was not significant for antioxidants alone (OR, 0.79; 99% CI, 0.56-1.13).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Development of Neovascular AMD.
plaindirectn = 5- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Comparisons of zinc vs no zinc and antioxidants vs no antioxidants (main effects) showed no statistically significant treatment difference.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > PRIMARY OUTCOME-VISUAL ACUITY LOSS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The OR for antioxidant plus zinc vs placebo estimated separately for participants in Categories 3 (OR, 0.76; 99% CI, 0.45-1.30)and 4 (OR, 0.52; 99% CI, 0.31-0.89) is in the direction of benefit for both groups.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Visual Acuity Loss Attributable to AMD.
hedgedcorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“An analysis of treatment effect showed no significant difference; OR estimates are 0.86 (99% CI, 0.55-1.34)for antioxidants, 1.13 (99% CI, 0.74-1.74)for zinc, and 1.08 (99% CI, 0.70-1.65)for antioxidants plus zinc (data not shown).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Development of Neovascular AMD.
plainn = 407- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The estimated 5-year probability of a 6-line (30letter) loss in visual acuity from the baseline score was 18% for participants assigned to placebo compared with 15% for participants assigned to either zinc (OR, 0.78; 99% CI, 0.55-1.12)or antioxidants (OR, 0.78; 99% CI, 0.55-1.12),and 13% for participants assigned to antioxidants plus zinc (OR, 0.67; 99% CI, 0.46-0.98).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Marked Visual Acuity Loss.
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Comparisons between the group taking the combination of antioxidants plus zinc with the groups taking either zinc or antioxidants were not statistically significant but favor the combination arm (combination vs zinc alone: OR, 0.88; 99% CI, 0.65-1.18;combination vs antioxidants alone: OR, 0.86; 99% CI, 0.63-1.16)(data not shown).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > PRIMARY OUTCOME-VISUAL ACUITY LOSS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“For participants in Categories 3 and 4, the OR estimates for this combined outcome for the antioxidants arm and the zinc arm compared with placebo are 0.79 (99% CI, 0.55-1.13)and 0.75 (99% CI, 0.53-1.07),respectively.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Visual Acuity Loss Attributable to AMD.
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“There are trends that favor treating with zinc alone or antioxidants alone but no statistically significant differences.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > PRIMARY OUTCOME-VISUAL ACUITY LOSS
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At 5 years, the estimated probability of progression to advanced AMD was 28% for those assigned to placebo, 23% and 22% for those assigned to antioxidants and zinc, respectively, and 20% for those assigned to antioxidants plus zinc.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > By Treatment
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Mortality risk in the antioxidants plus zinc arm was lower than in the placebo arm but this difference is also not statistically significant.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Third, for data in this study OR reductions are greater than estimates of RR reductions.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Odds reductions for the antioxidants plus zinc treatment were 24% for Category 3 participants and 48% for Category 4 participants.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants assigned to zinc arms more frequently reported difficulty swallowing the study tablets (17.8% vs 15.3%; P = .04)compared with participants taking formulations without zinc.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Conditions Reported at Follow-up
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“The treatment benefit is modest and participants in all treatment arms continue to progress to advanced AMD and lose vision over time.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“At the time of study enrollment, only 8% of AREDS participants were smokers and 49% were former smokers.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The treatment effect of the study formulations was in the beneficial direction for both AMD and visual acuity outcomes both in the group of participants choosing to supplement with Centrum at baseline and in the group not choosing Centrum at baseline (data not shown).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“For participants who had never smoked, the RR of death for those taking antioxidants alone was increased (RR, 1.57; 99% CI, 0.82-3.02)and suggested no effect on the combination arm (RR, 1.12; 99% CI, 0.56-2.24).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Mortality
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The effect of treatment on mortality stratified by baseline smoking status (current smoker, former smoker, never smoked) found no significant effect of the use of antioxidants alone on mortality for current smokers (RR, 0.99; 99% CI, 0.45-2.17)and a nonsignificant reduction in mortality for the combination arm (RR, 0.61; 99% CI, 0.24-1.56).”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Mortality
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Although both zinc and antioxidants plus zinc significantly reduce the odds of developing advanced AMD for participants in Categories 3 and 4, the only statistically significant reduction in rates of at least moderate visual acuity loss occurred in persons assigned to antioxidants plus zinc.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Despite the lack of convincing evidence, the marketing and use of antioxidants and zinc in eye-targeted formulations has become a common practice.30”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > CLINICAL SCIENCES
What the sources say
- Not checked — no full text of the sourcecites [30] 30. Sperduto RD, Ferris FL III, Kurinij N. Editorial. Do we have a nutritional treat- ment for age-related cataract or macular degeneration? Arch Ophthalmol. 1990; 108:1403-1405. source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“A data and safety monitoring committee monitored 5 end points from the 2 trials (AMD and cataract) simultaneously for both safety and efficacy.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STATISTICAL MONITORING
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Simple randomization, stratified by clinical center and AMD category, was used to assign treatment.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Randomization
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The results reported do not include these data, although inclusion of this information had no discernible effect on results.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > DATA QUALITY
plainn = 28- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The frequency of missed visits and mean follow-up time (6.3 years) did not differ by treatment group.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > DATA QUALITY
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants were randomly assigned to receive daily oral tablets containing: (1) antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; and beta carotene, 15 mg); (2) zinc, 80 mg, as zinc oxide and copper, 2 mg, as cupric oxide;(3) antioxidants plus zinc; or (4) placebo.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The Age-Related Eye Disease Study, an 11center double-masked clinical trial, enrolled participants in an AMD trial if they had extensive small drusen, intermediate drusen, large drusen, noncentral geographic atrophy, or pigment abnormalities in 1 or both eyes, or advanced AMD or vision loss due to AMD in 1 eye.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Written informed consent was obtained from all participants before enrollment.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STUDY POPULATION
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“All comparisons were made on an intention-to-treat basis.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STATISTICAL ANALYSES
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Results from an analysis of mean change in visual acuity (data not shown) were consistent with results from the repeated-measures analysis.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > PRIMARY OUTCOME-VISUAL ACUITY LOSS
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Because persons are the units of analysis, no adjustment for correlation between paired eyes is needed.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STATISTICAL ANALYSES
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Study medication tablets for the 4 treatment groups were identical in external appearance and similar in internal appearance and taste.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Masking
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“More than 99% of fundus photographs taken during the clinical trial were judged by the reading center to be of gradable quality for the development of advanced AMD.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > PHOTOGRAPHIC QUALITY
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Most participants (90%) had at least 5 years of follow-up.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > DATA QUALITY
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The frequency of these characteristics was similar among the 4 treatment groups and no large or statistically significant differences were found.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STATISTICAL ANALYSES
plainn = 3,609- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants without photographic or visual acuity follow-up were evenly distributed across treatment groups.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Procedures
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Prior to study initiation, the protocol was approved by an independent data and safety monitoring committee and by the institutional review board for each clinical center.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > STUDY POPULATION
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Estimated pill counts showed that most patients took 75% or more of the assigned medications and adherence was balanced by treatment.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“Persons who smoke are at increased risk for both AMD 50 and lung cancer.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
What the sources say
- Not matchedcites [50] 50. The Age-Related Eye Disease Study Research Group. Risk factors associated with age-related macular degeneration: a case-control study in the Age-Related Eye Disease Study: AREDS Report No 3. Ophthalmology. 2000;107:2224-2232.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Not matched
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Their results may be consistent with the AREDS finding of little or no treatment effect in slowing the progression of AMD in Category 2 participants.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
In the paper
“The AREDS clinical trial of cataract found no effect of treatment on the development of lens opacity, 46 and the proportion of participants with cataract surgery in 1 or both eyes during the study was balanced across treatment groups.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
What the sources say
- Not matchedcites [46] 46. Age-Related Eye Disease Study Research Group. A randomized, placebo- controlled clinical trial of high-dose supplementation with vitamins C and E and beta carotene for age-related cataract and vision loss: AREDS Report No. 9. Arch Ophthalmol. 2001;119:1439-1452.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“However, these comparisons are underpowered and the choice to use Centrum was confounded by the presence of AMD at study entry.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Tissue levels of the vitamins and minerals studied were not measured.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Using fundus photographs without fluorescein angiography to identify advanced AMD may delay the identification of advanced AMD events and may underestimate the absolute inci-dence.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“the assessment of the outcome is identical in each randomized treatment group.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
In the paper
“The dose of vitamin C (500 mg) used in the formulation is about 5 times what the general population receives from diet alone.44”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
What the sources say
- Not matchedcites [44] 44. Alaimo K, McDowell MA, Briefel RR, et al. Dietary intake of vitamins, minerals, and fiber of persons ages 2 months and over in the United States: Third National Health and Nutrition Examination Survey, Phase 1, 1988-91. Adv Data. 1994;14: 1-28.
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Not matched
The authors state this as an assumption.
There is no interaction between the antioxidant formulation and the zinc formulation.
“Sequential monitoring of end points assumed no interaction between the antioxidant formulation and the zinc formulation, so that only main effects were analyzed.”
The paper relies on this without support.
Visual acuity loss of at least 15 letters is a clinically meaningful outcome for AMD.
“at least a 15-letter decrease in the visual acuity score between baseline and each follow-up visit (equivalent to at least a doubling of the initial visual angle)”
The paper relies on this without support.
The examining ophthalmologist's attribution of visual acuity events to macular degeneration is accurate.
“only 13 of these events (7%) were thought by the examining ophthalmologist to be primarily related to macular degeneration.”
The paper relies on this without support.
Serum levels of antioxidants and zinc reflect adherence to study medication.
“These results indicate a definite serum response to each study ingredient.”
The paper relies on this without support.
The 400-IU dose of vitamin E is about 13 times the RDA and the dose of zinc as zinc oxide is about 5 times the RDA.
“The 400-IU dose of vitamin E is about 13 times the RDA and the dose of zinc as zinc oxide is about 5 times the RDA.”
The paper relies on this without support.
AREDS participants were relatively well-nourished compared with the general population.
“The AREDS participants were relatively well-nourished compared with the general population”
The paper relies on this without support.
Most cases of advanced AMD are identified with long-term follow-up.
“Most cases are identified with long-term follow-up”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The cited source doesn’t support the claim as written.
In the citing paper
“No significant side effects were noted in subjects who received high levels of therapeutic zinc (73).”
From Discovery of Human Zinc Deficiency: Its Impact on Human Health and Disease (2013) · cites this paper as [73]
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Large, multicenter, prospective randomized clinical trials have reported the effectiveness of using AREDS and AREDS 2 supplements in reducing AMD progression to geographic atrophy and neovascular disease [10,11].”
From Genetics and Age-Related Macular Degeneration: A Practical Review for Clinicians. (2024) · cites this paper as [10]
Experimental — accuracy not yet measuredThe source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“Zinc alone has decreased the incidence of blindness due to age-related macular degeneration in 25% of these elderly subjects, and, most important, increased longevity has also been reported in those treated with zinc (41,42).”
From Zinc supplementation decreases incidence of infections in the elderly: effect of zinc on generation of cytokines and oxidative stress (2007) · cites this paper as [41]
Experimental — accuracy not yet measuredIn the citing paper
“Zinc alone has decreased the incidence of blindness due to age-related macular degeneration in 25% of these elderly subjects, and, most important, increased longevity has also been reported in those treated with zinc (41,42).”
From Zinc supplementation decreases incidence of infections in the elderly: effect of zinc on generation of cytokines and oxidative stress (2007) · cites this paper as [41]
In the citing paper
“A long-term, still ongoing trial has been conducted for the past 10 y in patients with age-related macular degeneration who received 80 mg elemental zinc as oxide and 2 mg Cu to prevent copper deficiency (41).”
From Zinc supplementation decreases incidence of infections in the elderly: effect of zinc on generation of cytokines and oxidative stress (2007) · cites this paper as [41]
In the citing paper
“analyses have revealed protective effects from antioxidants, nuts, fish, and omega-3 polysaccharide unsaturated fatty acids (AREDS, 2001; Cho et al., 2001; Seddon et al., 1994, 2001; Smith et al., 2000).”
From Molecular pathology of age-related macular degeneration (2009) · cites this paper as AREDS, 2001
In the citing paper
“The Age-Related Eye Disease Study Group, supported by National Eye Institute/NIH, conducted an 11-center double-blind clinical trial in patients with dry-type AMD (73).”
From Discovery of Human Zinc Deficiency: Its Impact on Human Health and Disease (2013) · cites this paper as [73]
In the citing paper
“In the group taking the antioxidant plus zinc supplements, the risk of advanced AMD developing was reduced by ∼25% and vision loss by ∼19%.”
From Discovery of Human Zinc Deficiency: Its Impact on Human Health and Disease (2013) · cites this paper as [73]
In the citing paper
“In the group taking the vitamins alone, the risk of advanced AMD developing was decreased by 17%, and vision loss was decreased by 10%.”
From Discovery of Human Zinc Deficiency: Its Impact on Human Health and Disease (2013) · cites this paper as [73]
In the citing paper
“In the group taking zinc alone, the risk of advanced AMD developing was reduced by ∼21% and vision loss by 11%.”
From Discovery of Human Zinc Deficiency: Its Impact on Human Health and Disease (2013) · cites this paper as [73]
In the citing paper
“AREDS, a multicenter randomized and controlled clinical trial of oral supplements, demonstrated that high doses of antioxidant vitamin C, vitamin E, beta-carotene, zinc, and copper are effective in slowing the progression of advanced stages of AMD by 25% (4).”
From Unraveling a Multifactorial Late-Onset Disease: From Genetic Susceptibility to Disease Mechanisms for Age-Related Macular Degeneration (2009) · cites this paper as [4]
In the citing paper
“Treatment with antioxidant vitamins and zinc can reduce the risk of developing advanced age-related macular degeneration by about a quarter in those at least at moderate risk.”
From Age-related macular degeneration (2008) · cites this paper as [2]
In the citing paper
“A multicentre randomised trial has shown that oral supplements including high levels of antioxidants and minerals are effective in slowing the progression of advanced stages of age-related macular degeneration.2”
From Age-related macular degeneration (2008) · cites this paper as [2]
In the citing paper
“This was accompanied by a 19% reduction in the risk of moderate vision loss (three or more lines of vision loss on the visual acuity chart) at 5 years.”
From Age-related macular degeneration (2008) · cites this paper as [2]
In the citing paper
“the AREDS formulation of antioxidant multivitamins (vitamin C 500 mg, vitamin E 400 IU, beta-carotene 15 mg) and zinc (zinc oxide 80 mg and cupric oxide 2 mg) has been shown to reduce the risk of developing advanced age-related macular degeneration and its associated visual loss by as much as 25% over 5 years in individuals with at least moderate risk of age-related macular degeneration.2”
From Age-related macular degeneration (2008) · cites this paper as [2]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > COMMENT
“serum levels of each of the vitamins or minerals in the assigned study formulations in participants enrolled in the 3 AREDS clinics collecting specimens were elevated throughout the study.”
§ A Randomized, Placebo-Controlled, Clinical Trial of High-Dose Supplementation With Vitamins C and E, Beta Carotene, and Zinc for Age-Related Macular Degeneration and Vision Loss > Changes in Serum Levels of Antioxidants and Zinc
“Median percent change in serum level of copper from baseline ranges from a 3% decrease to a 2% increase among all participants regardless of study medication assignment, indicating no differential effect of zinc oxide with added cupric oxide on copper levels.”
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“Additionally, upon employing the AREDS-based criteria [14] for the classification of AMD subjects, it was similarly observed that there was no statistically significant association between the groups of subjects and their respective eth-nicities (Table 2).”
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Metadata
- Authors
- Age-Related Eye Disease Study Research Group
- Corresponding author
- Age-Related Eye Disease Study Research Group
- Venue
- Archives of Ophthalmology
- Publisher
- American Medical Association (AMA)
- Published
- 2001-10-01
- Volume
- 119
- Issue
- 10
- Pages
- 1417
- ISSN
- 0003-9950 (ISSN-L)
- PMC
- PMC1462955
- OpenAlex
- W2598520882
- Cited by
- 3,285
- References
- 61
- Citations by year
- 2026: 101 · 2025: 106 · 2024: 102 · 2023: 99 · 2022: 129 · 2021: 155 · 2020: 147 · 2019: 105 · 2018: 125 · 2017: 127 · 2016: 118 · 2015: 164 · 2014: 170 · 2013: 154 · 2012: 176
- FWCI
- 90.03
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Archives of Ophthalmology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- University of Wisconsin-Madison
- Wake Forest University
- University of Washington
- Georgetown University
- Università degli Studi di Parma
- National Institutes of Health (1z01ey000394-01, Z01 EY000394)
- Centers for Disease Control and Prevention
- National Eye Institute (Z01 EY000394-03)
- National Cancer Institute
- NIH Clinical Center
- Topics
- Health Sciences › Medicine › Ophthalmology › Retinal Diseases and Treatments
- Health Sciences › Medicine › Biochemistry (medical) › Antioxidant Activity and Oxidative Stress
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Retinal Imaging and Analysis
- Keywords
- age-related macular degeneration, vitamin C, vitamin E, beta-carotene, zinc supplementation, antioxidants, visual acuity loss, drusen, geographic atrophy, AMD progression, blindness prevention, AREDS, dietary supplements, serum zinc, copper supplementation, macular pigment optical density, retinal pigment epithelium, macular pigment
- MeSH terms
- Aged, Aged, 80 and over, Antioxidants, Ascorbic Acid, Double-Blind Method, Drug Evaluation, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Macular Degeneration, Male, Middle Aged, Prospective Studies, Risk Factors, Vision Disorders, Visual Acuity, Vitamin E, Zinc, Disease Progression, beta Carotene, Dietary Supplements
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